- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03266887
Vitamin D Levels and Survival in Cancer Patients
August 28, 2017 updated by: Icelandic Heart Association
Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer
Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of 25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with survival after cancer diagnosis.
We also wanted to assess the risk of being diagnosed with cancer in association with 25(OH)D levels.
In this population living just south of the arctic circle, vitamin D levels largely depend on dietary- and supplemental sources.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
5764
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
66 years to 98 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
In 1967, all 30,795 men and women living in the capital area of Iceland and born between 1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort study.
Approximately 19,000 attended the clinic at least once and became participants of the Reykjavik Study.
Subsequently, in 2002, a random sample of the cohort comprising 5,764 men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study (20).
Serum 25(OH)D was measured in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006.
Description
Inclusion Criteria:
To be part of the AGES-Reykjavik Study, initiated between 2002 and 2006.
Exclusion Criteria:
Diagnosed with cancer at study entry
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall mortality among cancer patients
Time Frame: Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
|
We tested the association between pre-diagnostic 25(OH)D levels and total survival
|
Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cancer-specific mortality among cancer patients
Time Frame: Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
|
We tested the association between pre-diagnostic 25(OH)D levels and cancer survival
|
Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-diagnostic 25(OH)D levels and cancer risk
Time Frame: Participants without cancer were followed from the study entry since 2002 until cancer diagnosis, death or end of the observation period whichever occurred first (December 31, 2014)
|
We tested the association between pre-diagnostic 25(OH)D levels and risk of being diagnosed with cancer
|
Participants without cancer were followed from the study entry since 2002 until cancer diagnosis, death or end of the observation period whichever occurred first (December 31, 2014)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2002
Primary Completion (Actual)
December 30, 2006
Study Completion (Actual)
December 30, 2006
Study Registration Dates
First Submitted
August 28, 2017
First Submitted That Met QC Criteria
August 28, 2017
First Posted (Actual)
August 30, 2017
Study Record Updates
Last Update Posted (Actual)
August 30, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- HI14010102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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